The dangers of infection from accidental contact with the sharpened points of used hypodermic needles are well documented. The proliferation of Human immunodeficiency Virus (HIV), combined with the increasing incidence of other bloodborne pathogens such as Hepatitis B Virus and Hepatitis C Virus, present healthcare workers with a serious occupational hazard. More than twenty known bloodborne pathogens, which are transmitted via blood and bodily fluids, are present inside the bore of a used needle and can be transmitted to another person after the needle has been used with an infected patent. The presence of any of these pathogens in infected patients poses a risk of transmitting a deadly disease to healthcare workers when virtually any procedure is performed in which a needle penetrates the patient's skin.
Infectious diseases have become the third leading cause of death; the prevalence of those diseases creates a growing need for needle protection devices that provide a margin of safety to the healthcare worker. Healthcare workers routinely perform several types of invasive hypodermic and intravenous procedures, such as injecting medicine, collecting blood, establish intravenous (i.v.) fluid administration, and inserting indwelling intravenous catheters. During or after these procedures, nurses and other healthcare personnel are routinely injured by the exposed sharpened end of the needle after use on a patient. Although the danger exists at several points in time, an injury by a needle point, sometimes called a “needle stick” injury, is most likely to occur between the moment that a needle is withdrawn from a patient and the time at which the contaminated needle is safely discarded.
The jobs of approximately 5.6 million workers in the United States place them at risk for accidental needle stick injuries. Medical literature cites approximately one million reported needle stick accidents that occur in the United States each year, with an additional 700,000 believed to be unreported. Prior to high rates of HIV and serum hepatitis, a needle stick injury was considered a routine nuisance that was accepted as part of providing patient care. However, a needle stick injury now carries the potential for a life-threatening transfer of infectious disease.
The great majority of hypodermic and intravenous needles are intended for a single use on an individual patient and are manufactured in a variety of designs, lengths, and gauges. Most simple needles are discarded after a single use into a biohazard collection container that contains the used needle and may also break the needle to prevent re-use. Despite all the obvious dangers associated with the use of hypodermic and intravenous needles, and the availability of many safety needle devices, unguarded needles are still routinely and predominately used in the marketplace. Due to cost considerations, many medical institutions continue to purchase unsafe needle devices.
One problem with many safety needle devices is that they are expensive and difficult to manufacture because of the intricacy of the design and the use of multiple components as part of the safety mechanism. Even when used, the incidence of failure is well known with many existing needle safety devices. Another problem associated with some of the present devices is that the protective device itself can injure the healthcare practitioner. When a protective device is difficult or clumsy to use, the action required to use the device can actually cause injury. As would be expected, the greater the number of active manipulations that must be made by hand with any safety apparatus containing a needle, the greater the risk of contact with the point. When the mechanism of use is awkward or uncomfortable, the risks naturally increase.
Moreover, any time that a safety device adds cost to a system, the added marginal cost will cause the safety device to be abandoned, or used less frequently, in a finite number of cases. Thus, simplicity and low cost are primary concerns when providing any safety device for use with an existing system. To enhance simplicity and reduce the costs of any safety system, important design criteria impact both the manufacturing process for producing the device and the operational use parameters of the device in everyday practice. Furthermore, the ideal safety device offers universal design that may be used with a large number of common devices, while also being able to be specifically designed and configured to cooperate with the underlying systems for which the safety margin is provided.
Therefore, the dangers inherent in the use of hypodermic and intravenous needles would be reduced by a safety device that has a low cost of manufacture, a simplicity of use, and that provides an effective needle protection apparatus with universal application.